Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT03099694
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2016-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
NHFOV vs. NCPAP as a Primary Treatment to Neonatal Respiratory Distress Syndrome(NRDS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': '15084335697@163.com', 'phone': '13508300283', 'title': 'Prof. Shi Yuan', 'organization': "Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, Key Laboratory of Pediatrics in Chongqing"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'nHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of nHFOV', 'otherNumAtRisk': 152, 'deathsNumAtRisk': 152, 'otherNumAffected': 0, 'seriousNumAtRisk': 152, 'deathsNumAffected': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'nCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 0, 'seriousNumAtRisk': 150, 'deathsNumAffected': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Required Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'nCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP'}, {'id': 'OG001', 'title': 'nHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of NHFOV'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during the first 7 days after birth', 'description': 'The criteria for endotracheal mechanical ventilation were as follows: severe respiratory acidosis (PaCO2 \\> 60 mmHg with pH\\<7.20), severe apnea and bradycardia (defined as recurrent apnea with \\> 3 episodes per hour associated with heart rate \\< 100/min, a single episode of apnea that required bag and mask ventilation), hypoxia (FiO2\\>0.5 with PaO2\\<50mmHg), severe respiratory distress, neonatal pulmonary hemorrhage, and cardiopulmonary arrest without effective resuscitation needing continued ventilation and rescue', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'the Incidence of Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'nCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP'}, {'id': 'OG001', 'title': 'nHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of NHFOV'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'first two months after birth', 'description': 'The criteria for intraventricular hemorrhage (IVH, ≥ grade Ⅲ): intraventricular hemorrhage with ventricular dilatation and intraventricular hemorrhage with paren- ehymal hemorrhage. Intraventricular hemorrhage (≥ grade Ⅲ) is worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'the Incidence of Pneumothorax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'nCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP'}, {'id': 'OG001', 'title': 'nHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of NHFOV'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during non-invasive ventilation, up to 7 days', 'description': 'the incidence of pneumothorax', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'the Incidence of Neonatal Necrotizing Enterocolitis(>Stage II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'nCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP'}, {'id': 'OG001', 'title': 'nHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of NHFOV'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during non-invasive ventilation, up to 7 days', 'description': "The criteria for neonatal necrotizing enterocolitis(\\>stage II): Unequivocal malfunction of the gastrointestinal tract is demonstrated clinically and by radiographic evaluation. Other disorders such as malrotation and volvulus and Hirschsprung's disease must be excluded.\n\nNeonatal necrotizing enterocolitis(\\>stage II) is worse outcome", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'the Incidence of Retinopathy of Prematurity (>Stage II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'nCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP'}, {'id': 'OG001', 'title': 'nHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of NHFOV'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at a post-menstrual age of 36 weeks or at discharge', 'description': 'The criteria for Retinopathy of prematurity (\\>Stage II); extraretinal fibrovascular proliferation neovascularization extends from ridge into the vitreous. Retinopathy of prematurity (\\>Stage II) is worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Score of Bayley Scales of Infant Development', 'timeFrame': '30 months', 'description': 'scores of Bayley Scales of Infant Development at 2 months old and 2 years old', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2021-09'}, {'type': 'SECONDARY', 'title': 'the Incidence of Bronchopulmonary Dysplasia(BPD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'nCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP'}, {'id': 'OG001', 'title': 'nHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of NHFOV'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at a post-menstrual age of 36 weeks or at discharge', 'description': 'BPD was defined according to the National Institutes of Health consensus definition: Need for O2 supplementation(FiO2\\>0.21) for at least 28 days after birth.\n\nBPD is worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'the Incidence of Abdominal Distention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'nCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP'}, {'id': 'OG001', 'title': 'nHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of NHFOV'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during non-invasive ventilation, up to 7 days', 'description': 'Abdominal circumference increase 2 centimeter during non-invasive ventilation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Time of Non-invasive Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'nCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP'}, {'id': 'OG001', 'title': 'nHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of NHFOV'}], 'classes': [{'categories': [{'measurements': [{'value': '81.0', 'groupId': 'OG000', 'lowerLimit': '40.0', 'upperLimit': '166.0'}, {'value': '78.5', 'groupId': 'OG001', 'lowerLimit': '48.0', 'upperLimit': '163.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'during non-invasive ventilation, up to 30 days', 'description': 'Hours', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'nCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP'}, {'id': 'OG001', 'title': 'nHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of NHFOV'}], 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000', 'lowerLimit': '19.0', 'upperLimit': '41.0'}, {'value': '31.0', 'groupId': 'OG001', 'lowerLimit': '18.5', 'upperLimit': '41.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'during hospitalization, up to 60 days', 'description': 'Days', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Predischarge Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'nCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP'}, {'id': 'OG001', 'title': 'nHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of NHFOV'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during hospitalization, up to 60 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of O2 Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'nCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP'}, {'id': 'OG001', 'title': 'nHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of NHFOV'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '17.0'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '17.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'during hospitalization, up to 60 days', 'description': 'Days', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Thick Secretions Causing an Airway Obstruction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'nCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP'}, {'id': 'OG001', 'title': 'nHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of NIPPV'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during non-invasive ventilation, up to 15 days', 'description': 'determined by the clinician', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'nCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP'}, {'id': 'FG001', 'title': 'nHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of NHFOV'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '170'}, {'groupId': 'FG001', 'numSubjects': '170'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'From May, 2017, through July, 2018, a total of 18 centers screened 2509 infants, of which 1385 were eligible. We recruited 340 infants (170 in each group), to account for dropouts. Finally, 302 infants completed the trial (152 in NHFOV; 150 in NCPAP group.)', 'preAssignmentDetails': '1045 Did not undergo randomization\n\n* 663 Refused to participate\n* 382 NHFOV devices not available'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'nCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP'}, {'id': 'BG001', 'title': 'nHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of NIPPV'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30.9', 'spread': '1.8', 'groupId': 'BG000'}, {'value': '30.6', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '30.7', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Multiple birth', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Mothers of infants', 'unitOfMeasure': 'Participants'}, {'title': 'Antenatal steroids', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Mothers of infants', 'unitOfMeasure': 'Participants'}, {'title': 'Cesarean delivery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Mothers of infants', 'unitOfMeasure': 'Participants'}, {'title': 'Premature rupture of membranes>18h', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Mothers of infants', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational diabetes mellitus', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Mothers of infants', 'unitOfMeasure': 'Participants'}, {'title': 'Birth Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1582', 'spread': '343', 'groupId': 'BG000'}, {'value': '1564', 'spread': '367', 'groupId': 'BG001'}, {'value': '1572', 'spread': '351', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-13', 'size': 920372, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-23T05:05', 'hasProtocol': True}, {'date': '2017-07-13', 'size': 188797, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-02-23T07:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 340}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2018-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2016-11-17', 'resultsFirstSubmitDate': '2018-10-07', 'studyFirstSubmitQcDate': '2017-04-03', 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-07', 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Required Intubation', 'timeFrame': 'during the first 7 days after birth', 'description': 'The criteria for endotracheal mechanical ventilation were as follows: severe respiratory acidosis (PaCO2 \\> 60 mmHg with pH\\<7.20), severe apnea and bradycardia (defined as recurrent apnea with \\> 3 episodes per hour associated with heart rate \\< 100/min, a single episode of apnea that required bag and mask ventilation), hypoxia (FiO2\\>0.5 with PaO2\\<50mmHg), severe respiratory distress, neonatal pulmonary hemorrhage, and cardiopulmonary arrest without effective resuscitation needing continued ventilation and rescue'}], 'secondaryOutcomes': [{'measure': 'the Incidence of Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ)', 'timeFrame': 'first two months after birth', 'description': 'The criteria for intraventricular hemorrhage (IVH, ≥ grade Ⅲ): intraventricular hemorrhage with ventricular dilatation and intraventricular hemorrhage with paren- ehymal hemorrhage. Intraventricular hemorrhage (≥ grade Ⅲ) is worse outcome.'}, {'measure': 'the Incidence of Pneumothorax', 'timeFrame': 'during non-invasive ventilation, up to 7 days', 'description': 'the incidence of pneumothorax'}, {'measure': 'the Incidence of Neonatal Necrotizing Enterocolitis(>Stage II)', 'timeFrame': 'during non-invasive ventilation, up to 7 days', 'description': "The criteria for neonatal necrotizing enterocolitis(\\>stage II): Unequivocal malfunction of the gastrointestinal tract is demonstrated clinically and by radiographic evaluation. Other disorders such as malrotation and volvulus and Hirschsprung's disease must be excluded.\n\nNeonatal necrotizing enterocolitis(\\>stage II) is worse outcome"}, {'measure': 'the Incidence of Retinopathy of Prematurity (>Stage II)', 'timeFrame': 'at a post-menstrual age of 36 weeks or at discharge', 'description': 'The criteria for Retinopathy of prematurity (\\>Stage II); extraretinal fibrovascular proliferation neovascularization extends from ridge into the vitreous. Retinopathy of prematurity (\\>Stage II) is worse outcome.'}, {'measure': 'The Score of Bayley Scales of Infant Development', 'timeFrame': '30 months', 'description': 'scores of Bayley Scales of Infant Development at 2 months old and 2 years old'}, {'measure': 'the Incidence of Bronchopulmonary Dysplasia(BPD)', 'timeFrame': 'at a post-menstrual age of 36 weeks or at discharge', 'description': 'BPD was defined according to the National Institutes of Health consensus definition: Need for O2 supplementation(FiO2\\>0.21) for at least 28 days after birth.\n\nBPD is worse outcome.'}, {'measure': 'the Incidence of Abdominal Distention', 'timeFrame': 'during non-invasive ventilation, up to 7 days', 'description': 'Abdominal circumference increase 2 centimeter during non-invasive ventilation'}, {'measure': 'The Time of Non-invasive Ventilation', 'timeFrame': 'during non-invasive ventilation, up to 30 days', 'description': 'Hours'}, {'measure': 'Length of Hospitalization', 'timeFrame': 'during hospitalization, up to 60 days', 'description': 'Days'}, {'measure': 'Predischarge Mortality', 'timeFrame': 'during hospitalization, up to 60 days'}, {'measure': 'Length of O2 Therapy', 'timeFrame': 'during hospitalization, up to 60 days', 'description': 'Days'}, {'measure': 'Number of Participants With Thick Secretions Causing an Airway Obstruction', 'timeFrame': 'during non-invasive ventilation, up to 15 days', 'description': 'determined by the clinician'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NRDS', 'nHFOV', 'nCPAP', 'preterm infants'], 'conditions': ['Preterm Infants']}, 'referencesModule': {'references': [{'pmid': '33827081', 'type': 'DERIVED', 'citation': 'Zhu X, Feng Z, Liu C, Shi L, Shi Y, Ramanathan R; NHFOV study group. Nasal High-Frequency Oscillatory Ventilation in Preterm Infants with Moderate Respiratory Distress Syndrome: A Multicenter Randomized Clinical Trial. Neonatology. 2021;118(3):325-331. doi: 10.1159/000515226. Epub 2021 Apr 7.'}, {'pmid': '29898763', 'type': 'DERIVED', 'citation': 'Zhu XW, Shi Y, Shi LP, Liu L, Xue J, Ramanathan R; NHFOV Study Group. Non-invasive high-frequency oscillatory ventilation versus nasal continuous positive airway pressure in preterm infants with respiratory distress syndrome: Study protocol for a multi-center prospective randomized controlled trial. Trials. 2018 Jun 14;19(1):319. doi: 10.1186/s13063-018-2673-9.'}]}, 'descriptionModule': {'briefSummary': 'The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -noninvasive high-frequency oscillatory ventilation (nHFOV) or nasal continuous positive airway pressure (nCPAP) -as a primary mode of ventilation in premature infants with RDS．', 'detailedDescription': 'Background: Invasive mechanical ventilation is associated with development of adverse pulmonary and non-pulmonary outcomes in very low birth weight infants. Various modes of non-invasive respiratory support are being increasingly used to minimize the incidence of bronchopulmonary dysplasia (BPD). The aim of this trials to compare the effect of noninvasive high-frequency oscillatory ventilation (NHFOV) and nasal continuous positive airway pressure (NCPAP) in preterm infants with respiratory distress syndrome (RDS) as a primary noninvasive ventilation support mode.\n\nMethods/Design:In this multicenter, randomized, controlled trial, 300 preterm infants at gestational age (GA) less than 34 weeks with a diagnosis of RDS will be randomized to NHFOV or NCPAP as a primary mode of non-invasive respiratory support. Study will be conducted in 18 tertiary neonatal intensive care units in China.\n\nThe primary outcome is the need for invasive mechanical ventilation (IMV)during the first 7 days after enrollment in preterm infants randomized to the two groups. The secondary outcomes include days of hospitalization, days on noninvasive respiratory support, days on IMV, days on supplemental oxygen, mortality, need for surfactant, incidence of retinopathy of prematurity(ROP) and bronchopulmonary dysplasia(BPD), occurrence of abdominal distention, air leaks, intraventricular hemorrhage (IVH ≥ grade 3) and necrotizing enterocolitis (NEC\\> II stage). Other secondary outcomes include scores of Bayley Scales of Infant Development at 2 months and 2 years of corrected age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n(1)Gestational age (GA) is from 26 to 34 weeks; (2) diagnosis of RDS. The diagnosis of RDS will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings; (3) RDS Silverman score\\>5; (4) informed parental consent has been obtained.\n\nExclusion criteria\n\n(1) severe RDS requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation7; (2)major congenital malformations or complex congenital heart disease; (3) group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage; (4) cardiopulmonary arrest needing prolonged resuscitation; (5) transferred out of the NICUs without treatment.'}, 'identificationModule': {'nctId': 'NCT03099694', 'briefTitle': 'NHFOV vs. NCPAP as a Primary Treatment to Neonatal Respiratory Distress Syndrome(NRDS)', 'organization': {'class': 'OTHER', 'fullName': "Jiulongpo No.1 People's Hospital"}, 'officialTitle': 'Noninvasive Ventilation for Preterm Neonates With Respiratory Distress Syndrome: a Multi-center Randomized Controlled Trial', 'orgStudyIdInfo': {'id': "Jiulongpo People's Hospital"}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'nCPAP', 'description': 'nasal continuous positive airway pressure (nCPAP) - as a primary mode of ventilation in premature infants with RDS', 'interventionNames': ['Procedure: nasal continuous positive airway pressure (nCPAP)']}, {'type': 'EXPERIMENTAL', 'label': 'nHFOV', 'description': 'noninvasive high-frequency ventilation (nHFOV) as a primary mode of ventilation in premature infants with RDS', 'interventionNames': ['Procedure: noninvasive high-frequency ventilation (nHFOV)']}], 'interventions': [{'name': 'noninvasive high-frequency ventilation (nHFOV)', 'type': 'PROCEDURE', 'description': 'NHFOV will be provided by a high frequency ventilator (CNO, Medin, Germany or SLE 5000, UK). NHFOV will be provided via binasal prongs.', 'armGroupLabels': ['nHFOV']}, {'name': 'nasal continuous positive airway pressure (nCPAP)', 'type': 'PROCEDURE', 'description': 'Infants assigned to the NCPAP group will be started on a pressure of 6 cmH2O (range: 6-8 cmH2O) by CPAP system (CNO Medin, Germany, Carefusion, USA)', 'armGroupLabels': ['nCPAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400000', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Xingwang Zhu', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Shi Yuan, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Third Military Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Dr. Kris Sekar, Professor of Pediatrics, Oklahoma University Medical Center, Oklahoma, Dr. Jatinder Bhatia, Professor of Pediatrics, Medical College of Georgia, Georgia Health Sciences University, Augusta, Georgia, and Dr. Rowena Cayabyab, MD., MPH (Biostatistics and Epidemiology) Assistant Professor of Pediatrics, Keck School of Medicine of the University of Southern California, Los Angeles, California will serve as DSMB members. Dr. Cayabyab will also serve as consultant for statistical analysis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xingwang Zhu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guiyang Maternity and Child Health Care Hospital', 'class': 'OTHER'}, {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, {'name': "Children's Hospital of Chongqing Medical University", 'class': 'OTHER'}, {'name': 'Chongqing Maternal and Child Health Hospital', 'class': 'OTHER'}, {'name': 'The Second Hospital of Shandong University', 'class': 'OTHER'}, {'name': "Yan'an Affiliated Hospital of Kunming Medical University", 'class': 'OTHER'}, {'name': "The Children's Hospital of Zhejiang University School of Medicine", 'class': 'OTHER'}, {'name': "Hunan Children's Hospital", 'class': 'OTHER_GOV'}, {'name': "Zhengzhou Children's Hospital, China", 'class': 'OTHER'}, {'name': "Chengdu Women's and Children's Central Hospital", 'class': 'OTHER'}, {'name': "The People's Hospital of Dehong Autonomous Prefecture", 'class': 'OTHER'}, {'name': "Kunming Children's Hospital", 'class': 'OTHER'}, {'name': 'Chongqing Three Gorges Central Hospital', 'class': 'OTHER'}, {'name': "Shanxi Provincial Maternity and Children's Hospital", 'class': 'OTHER'}, {'name': 'University of Southern California', 'class': 'OTHER'}, {'name': 'Vilnius University', 'class': 'OTHER'}, {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, {'name': 'Guangdong Women and Children Hospital', 'class': 'OTHER'}, {'name': "Nanjing Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of neonatology', 'investigatorFullName': 'Xingwang Zhu', 'investigatorAffiliation': "Jiulongpo No.1 People's Hospital"}}}}